N/A

GUDID 00821684074176

ATHERECTOMY FG02550 CUTTERDRIVER V04

Covidien LP

Mechanical atherectomy system catheter, peripheral

• Primary Device ID: 00821684074176
• NIH Device Record Key: 4fc5677b-abc5-406c-969d-1828cf3e7ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: FG02550
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684074176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061188

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00821684074176]

Radiation Sterilization

[00821684074176]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-01

On-Brand Devices [N/A]

• 00821684074176: ATHERECTOMY FG02550 CUTTERDRIVER V04
• 00763000571092: ACCY 3755-40 TUNNELNG TOOL DBS EMAN LL61